Efficacy and Safety Study of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 16 - Any |
Updated: | 3/13/2019 |
Start Date: | April 14, 2017 |
End Date: | August 13, 2021 |
Contact: | Shire Contact |
Email: | ClinicalTransparency@shire.com |
Phone: | 866-842-5335 |
A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients
The purpose of this study is to compare the efficacy of maribavir to valganciclovir for the
treatment of cytomegalovirus (CMV) infection in asymptomatic hematopoietic stem cell
transplant (HSCT) recipients.
treatment of cytomegalovirus (CMV) infection in asymptomatic hematopoietic stem cell
transplant (HSCT) recipients.
Inclusion Criteria:
- Be able to provide written, personally signed, and dated informed consent to
participate in the study before completing any study-related procedures. As
applicable, a parent/both parents or legally authorized representative (LAR) must
provide signature of informed consent and there must be documentation of assent by the
participants before completing any study-related procedures.
- Be greater than or equal to (>=) 16 years of age at the time of consent.
- Be a recipient of hematopoietic stem cell transplant.
- Have a documented asymptomatic CMV infection, with a screening value of CMV DNA >=1365
International Units per millilitre (IU/mL) to less than or equal to (<=) 273000 IU/mL
in whole blood or >= 455 IU/mL to <= 91000 IU/mL in plasma in 2 consecutive
assessments, separated by at least 1 day, as determined by local or central specialty
laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative
CMV DNA results. Both samples should be taken within 14 days prior to randomization
with second sample obtained within 5 days prior to randomization. Same laboratory and
same sample type (whole blood or plasma) should be used for these assessments.
Asymptomatic CMV infection is defined as an infection that does not present with
tissue invasive CMV disease, as assessed by the investigator. Participants with CMV
DNA less than (<) 910 and >= 455 IU/mL in plasma or < 2730 and >= 1365 IU/mL in whole
blood will also need to meet at least 1 of the following criteria for high-risk CMV
infection to be eligible:
1. Human leukocyte antigen (HLA)-related (sibling) donor with at least 1 mismatch at
1 of the following 3 HLA-gene loci: HLA-A, -B or -DR,
2. Haploidentical donor
3. Unrelated donor with at least 1 mismatch at 1 of the following 4 HLA -gene loci:
HLA-A, -B, -C and -DRB1,
4. Use of umbilical cord blood as stem cell source,
5. Use of ex vivo T-cell-depleted grafts,
6. Grade 2 or greater graft-versus-host-disease (GVHD), requiring the use of
systemic corticosteroids (defined as the use of >= 1 milligram per kilogram per
day (mg/kg/day) of prednisone or equivalent dose of another corticosteroid).
- Have the current CMV infection as the first episode of CMV viremia after HSCT, either
primary or reactivation, which in the investigator's opinion requires treatment.
- Per investigator's judgment, be eligible for treatment with valganciclovir.
- Have all of the following results as part of screening laboratory assessments (results
from either the central laboratory or a local laboratory can be used for
qualification):
1. Absolute neutrophil count to >= 1000 per cubic millimeter (/mm^3) [1.0 x 10^9/L].
2. Platelet count >= 25,000/mm^3 [25 x 10^9/L].
3. Hemoglobin >= 8 grams per deciliter (g/dL).
4. Estimated creatinine clearance >=30 milliliters per minute (mL/min).
- Have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test at
screening, if a female of child bearing potential. Urine pregnancy tests may be done
per institutional requirements; however they are not sufficient for eligibility
determination. Sexually active females of child bearing potential must agree to comply
with any applicable contraceptive requirements of the protocol. If male, must agree to
use an acceptable method of birth control, as defined in the protocol, during the
study treatment administration period and for 90 days afterward the last dose of study
treatment.
- Be able to swallow tablets.
- Have life expectancy of >= 8 weeks.
- Weigh >= 40 kilograms (kg).
- Be willing and have an understanding and ability to fully comply with study procedures
and restrictions defined in the protocol.
Exclusion Criteria:
- Have CMV tissue invasive disease as assessed by the investigator at the time of
screening and randomization at Visit 2/Day 0.
- Have a CMV infection that is known to be genotypically resistant to ganciclovir,
valganciclovir, foscarnet, or cidofovir based on documented evidence.
- Be presenting with recurrent CMV infection (defined as a new detection of CMV
infection in a participants who had at least one previously documented episode of CMV
infection post-transplant, and who has had at least 2 weeks of undetectable CMV DNA
between the episodes during active surveillance, based on same local laboratory and
same sample type). The Participants must also have been off any anti-CMV treatment
between the current and prior infection. Otherwise, the current infection may be
considered continuation of the prior infection.
- Require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for
conditions other than CMV when study treatment is initiated (example: herpes simplex
virus [HSV] co-infection requiring use of any of these agents after the randomization)
or would need a co-administration with maribavir for CMV infection.
- Be receiving leflunomide, letermovir, or artesunate when study treatment is initiated.
Note: Participants who may be receiving leflunomide must discontinue the use at least 14
days prior to randomization at Visit 2/Day 0 and the first dose of study treatment.
Participants receiving letermovir must discontinue use 3 days prior to first dose of study
treatment. Participants receiving artesunate must discontinue the use prior to the first
dose of study treatment.
- Be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet or
cidofovir) for the current CMV infection for longer than 72 hours.
- Have known hypersensitivity to the active substance or to an excipient of the study
treatments.
- Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24
hours prior to the first dose of study treatment that would preclude administration of
oral medication.
- Require mechanical ventilation or vasopressors for hemodynamic support at the time of
randomization.
- Be female and pregnant or nursing.
- Have previously completed, discontinued, or have been withdrawn from this study.
- Have received any investigational agent with known anti-CMV activity within 30 days
before initiation of study treatment or CMV vaccine at any time.
- Have received any unapproved agent or device within 30 days before initiation of study
treatment.
- Have any clinically significant medical or surgical condition that, in the
investigator's opinion, could interfere with interpretation of study results,
contraindicate the administration of the assigned study treatment, or compromise the
safety or well-being of the participant.
- Have previously received maribavir.
- Have serum aspartate aminotransferase (AST) greater than (>) 5 times upper limit of
normal (ULN) at screening, or serum alanine aminotransferase (ALT) > 5 times ULN at
screening, or total bilirubin >= 3.0 x ULN at screening (except for documented
Gilbert's syndrome), as analyzed by local or central lab.
- Have known (previously documented) positive results for human immunodeficiency virus
(HIV). Participants must have a confirmed negative HIV test result within 3 months of
study entry or, if unavailable, be tested by a local laboratory during the screening
period.
- Have active malignancy with the exception of nonmelanoma skin cancer, as determined by
the investigator. Participants who experience relapse or progression of their
underlying malignancy (for which HSCT was performed), as determined by the
investigator, are not to be enrolled.
- Be undergoing treatment for acute or chronic hepatitis C
We found this trial at
27
sites
Westmead, New South Wales 2145
Principal Investigator: Emily Blyth, MBBS
Phone: +61298457073
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201 Dowman Dr
Atlanta, Georgia 30303
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: George Lyon, MD
Phone: 404-712-2051
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Principal Investigator: John Baddley, MD, MSPH
Phone: 205-934-5191
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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5801 South Ellis Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
773.702.1234
Principal Investigator: Kathleen Mullane, DO, PharmD
Phone: 773-702-1665
University of Chicago One of the world's premier academic and research institutions, the University of...
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Jo-Anne Young, MD
Phone: 612-625-8642
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Austin, Texas 78704
Principal Investigator: Aravind Ramakrishnan, MD
Phone: 201-575-6904
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1800 Orleans St.
Baltimore, Maryland 21287
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Robin Avery, MD
Phone: 410-614-6702
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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655 West Baltimore Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
(410) 706-7410
Principal Investigator: Jean Yared, MD
Phone: 410-328-0386
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
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Boston, Massachusetts 02115
Principal Investigator: Francisco Marty, MD
Phone: 617-732-8881
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
Denver, Colorado 80218
720-754-4800
Principal Investigator: Richard Nash, MD
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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Detroit, Michigan 48202
Principal Investigator: George Alangaden, MD
Phone: 313-916-5401
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30 Prospect Ave
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Scott Rowley, MD
Phone: 551-996-5234
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
Principal Investigator: Roy Chemaly, MD
Phone: 713-792-5381
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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757 Westwood Plaza
Los Angeles, California 90024
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Drew Winston, MD
Phone: 310-825-6264
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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2160 South 1st Avenue
Maywood, Illinois 60153
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Patrick Hagen, MD
Phone: 708-327-3157
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Parameswaran Hari, MD
Phone: 414-805-4600
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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2300 Patterson Street
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Principal Investigator: Carlos Bachier, MD
Phone: 210-575-6904
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333 Cedar St
New Haven, Connecticut 06504
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Maricar Malinis, MD
Phone: 203-785-3561
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New York, New York 10021
Principal Investigator: Tsiporah Shore, MD
Phone: 212-746-2646
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Genovefa Papanicolaou, MD
Phone: 212-639-8361
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Ran Reshef, MD, MSc
Phone: 212-342-0530
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Emily Blumberg, MD
Phone: 215-662-7066
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Rochester, Minnesota 55905
Principal Investigator: Raymund Razonable, MD
Phone: 507-284-3747
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San Antonio, Texas 78229
Principal Investigator: Paul Shaughnessy, MD
Phone: 210-575-8500
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Seattle, Washington 98108
Principal Investigator: Thomas Chauncey, MD
Phone: 206-764-2969
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450 Serra Mall
Stanford, California 94305
Stanford, California 94305
(650) 723-2300
Principal Investigator: Janice Brown, MD
Phone: 650-868-8073
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Worcester, Massachusetts 01605
Principal Investigator: Laura Gibson, MD
Phone: 508-856-1978
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